Universitätsklinikum Würzburg

UKW Universitätsklinikum Würzburg

Ospedale san Raffaele

Ospedale san Raffaele

Universidad de Navarra

Universidad de Navarra

Centre Hopitalier regional et Universitaire de Lille

Chu de Lille

Bundesinstitut für Impfstoffe und Biomedizinische Arzneimittel

Bundesinstitut für Impfstoffe und Biomedizinische Arzneimittel

DRK- Blutspendedienst Baden-Wuerttemberg-Hessen GmbH

DRK- Blutspendedienst Baden-Wuerttemberg-Hessen GmbH

Myeloma Patients Europe

Myeloma Patients Europe

NBE Therapeutics

 NBE therapeutics Innovating Medicines

T-CURX GmbH

T-CURX GmbH

ARTTIC SAS

ARTTIC

The Team

The CARAMBA Consortium consists of ten partners from six different European countries:

Partners

Countries

Patients

Universitaetsklinikum Wuerzburg

General information

The Universitätsklinikum Wuerzburg (UKW) group is recognized internationally as a ‘Center of Excellence in Stem Cell Transplantation and Cell Therapy’, runs one of the largest leukemia (>100 acute leukemia patients per year) and stem cell transplantation programs in Germany (>280 per year) and has a designated Phase I Unit for early clinical studies. The UKW group was the first in Europe to explore T cell adoptive immunotherapy to treat infections after bone marrow transplantation in leukemia patients, and pioneered the use of bi-specific antibodies to redirect T cells to treat certain types of leukemia and lymphoma. The UKW group is already participating in several industry-sponsored clinical trials with BCMA-specific CAR-T cells in multiple myeloma and CD19- specific CAR-T cells in leukemia and lymphoma and has thus far treated the highest number of patients with CD19 CAR-T cells in Germany.

The UKW group runs one of the largest clinical programs in multiple myeloma in Europe, with more than 50 newly diagnosed patients and more than 1.000 myeloma in-patient and out-patient visits per year, and a patient registry of more than 5.000 myeloma patients. The myeloma program has a decade-long track record in the development and clinical evaluation of novel treatment concepts in myeloma and is consulted by myeloma patients that come to Würzburg from all-over Germany and Europe. A dedicated myeloma clinical service the ‘Wilhelm-Sander Therapieeinheit Multiples Myelom’ has been opened in 2015 and integrates multi-disciplinary clinical care to the benefit of myeloma patients.

The Hudecek laboratory is conducting translational research in tumor immunology and adoptive cancer immunotherapy with CAR-T cells and has garnered widespread visibility and attention in Europe and the US as a rapidly expanding, innovative research group in cell and gene therapy.

Role in CARAMBA

The Universitätsklinikum Würzburg (UKW) is the coordinating institution in CARAMBA and responsible for the successful conduct of the phase I/IIa clinical trial with SLAMF7 CAR-T cells, being an essential recruitment and treatment center. The UKW team will also lead the effort for obtaining German regulatory approval for the trial and project management.

Project staff

The Universitaetsklinikum Wuerzburg team

Michael Hudecek

Coordinator and Group Leader, Department of Internal Medicine II


Dr. Hudecek joined the University of Würzburg in 2012 as a clinical fellow and research group leader. His group is working in the field of tumor immunology and the development and clinical translation of adoptive immunotherapy of cancer with tumor-specific T cells.

Specific expertise: CAR design and evaluation; CAR/TCR Gene transfer; T cell immunotherapy; Tumor immunology.

Hermann Einsele

Full Professor of Internal Medicine, Director of the Department of Internal Medicine II


Specific expertise:
Multiple Myeloma, Stem cell transplantation, Adoptive T cell therapy, Immune monitoring.

Sophia Danhof

Clinician Scientist

Leading the CARAMBA clinical trial at UKW.

Specific expertise: Hematological malignancies,  Cellular therapy, SLAMF7 CAR-T cells.

Julia Beckmann

Scientist and Project Manager

Involved in clinical trial preparation.

Martin Kortüm

Clinician Scientist and Group leader involved in response assessment and monitoring.

Specific expertise: Hematological malignancies, Next-generation sequencing for risk stratification and therapeutic intervention in myeloma.

Sabrina Prommersberger

Scientist

Involved in clinical trial preparation, monitoring and next-generation CAR development.

Specific expertise: Tumor immunology, SLAMF7 CAR-T cells.

Address

Universitaetsklinikum Wuerzburg
Josef-Schneider-Str. 2
97080 Würzburg

www.ukw.de
  Email

Patient Contact

TBD after trial initiation

Ospedale san Raffaele

General information

As one of the leading private scientific research institutes in Italy, recognized by the Italian Ministry of Health as a Research Hospital (IRCCS), Ospedale San Raffaele comprises both clinical and research activities, conducted by a highly specialized and qualified hospital with 1,308 beds and a research institute with more than 1,500 basic, clinical and translational scientists. OSR integrates its research with the education and training activities conducted within the Università Vita-Salute San Raffaele (UniSR) which comprises the faculties of medicine, psychology and philosophy and provides specialized post graduate courses, residency programs in various medical specialties, and international PhD programs. OSR performs cutting-edge science and aims at advancing the knowledge about human diseases and novel therapies through translational research. OSR can count on over 50 clinical specialties, 4 Research Divisions, 4 Research Institutes and 3 Research Centers (http://www.hsr.it/research/). In particular OSR excellence research fields are: Oncology; Neuroscience; Metabolic and Cardiovascular Sciences; Regenerative Medicine, Stem Cells and Gene Therapy; Immunology, Transplantation and Infectious Diseases; Genetics and Cell Biology; Genomics, Bioinformatics and Imaging technologies; advanced technologies for Health and Wellbeing.

Role in CARAMBA

The Ospedale San Raffaele will be responsible for the GLP development of CARAMBA cells and the Phase I/IIa clinical study. It will also contribute to scaling-up the GMP production of cells, facilitating its regulatory approval, following up with patients and preclinical developing of next generation CAR immunotherapies.

Project staff

The Ospedale san Raffaele team

Fabio Ciceri

Head of the Clinical Hematology and Bone Marrow Transplantation Unit and Deputy Director of the Division of Regenerative Medicine, Stem Cell and Gene Therapy (DReAM-Gene) at OSR, and Full Professor at UniSR.

Specific expertise: more than 25 years experience in early-stage clinical development of cell and gene therapy strategies for non-malignant and malignant hematological diseases, and more recently also degenerative diseases (Duchenne muscular dystrophy) in conjunction with academic (Telethon) and non-academic (Molmed SpA, GSK) sponsors.

Monica Casucci

Senior Researcher, Innovative Immunotherapies Unit, DITID at OSR.

Specific expertise: Lead of preclinical development, expert of the CD44v6-CAR TK approach.

Marta Moresco

Project and Grant Manager

Silvia Arcangeli

Post-doctoral Researcher

Sara Mastaglio

Sara Mastaglio

Staff Member in the hematology and bone marrow transplant unit.

Address

Ospedale San Raffaele
Via Olgettina 60
20132 Milano

http://www.hsr.it/research/
  Email

Patient Contact

Grazia Consoli
  Email

Centre HoSpitalier regional et Universitaire de Lille

General information

The Lille University Hospital (CHU-Lille) is a large and experienced clinical and research facility that provides a strong infrastructure relevant for the proposed project, including one of the largest clinical myeloma programs in Europe. The department has 58 in-patients beds and 30 day-care beds with additional out-patients facilities (100 patients/day). Regarding myeloma, there are three full-time consultants dedicated to the care of myeloma patients. A large bone marrow transplantation unit performs more than 100 allogeneic transplants per year. There are three full time consultants dedicated to the management of these patients.

The clinical trial unit is led by Dr Petillon with trained trial nurses and data managers (12), experienced in both clinical trials including early phase and bone marrow transplant. Additionally, it is part of a translational research program in multiple myeloma within the URM S1128 INSERM unit and has access to a large molecular biology sequencing platform.

Role in CARAMBA

The Lille University Hospital is a participating center in the CARAMBA clinical study and an essential recruitment component and treatment center in this clinical trial. The immunology and hematology labs are able to perform all CAR-T cell enumeration and post-infusion toxicity monitoring as well as MRD by flow cytometry and NG. The CHU-Lille will also take responsibility for obtaining regulatory approval for the trial in France.

Project staff

Ibrahim Yakoub-Agha

Ibrahim Yakoub-Agha

Professor of Hematology, head of the Hematopoietic Stem Cell Transplantation Unit and past president of the Francophone Society of Bone Marrow Transplantation and Cell Therapy (SFGM-TC)


Specific expertise:

Allogeneic Stem Cell Transplantation especially in patients with Myelodysplastic Syndrome and expert in CAR-T approaches.

Myriam Labalette

Head of immunology laboratory of the Lille university hospital.


Specific expertise:

in histocompatibility and cellular immunology of hematopoetic stem cell transplantation.

Leonardo Magro

Physician at the transplantation unit at the CHRU-Lille.


Specific expertise:

in managing patients with CAR-T cells.

Salomon Manier

Instructor in Medicine; Department of Hematology, Lille University; INSERM UMR-S 1172


Specific expertise:

Investigator of several Multiple Myeloma clinical trials. Head of a research lab working on gene dependency in Myeloma.

Thierry Facon

Professor of Hematology and head of the Department of Hematology, Lille University Hospital


Specific expertise:

Lead of several pivotal clinical trials in the field of myeloma with an internationally renowned expertise is myeloma, implicated in the care of approximately 300 myeloma patients per year, 60 newly diagnosed patients and 100 relapsed and refractory patients per year.

Valerie Coiteux

Physician at the transplantation unit at the CHRU-Lille.


Specific expertise:
in managing patients with CAR-T cells.

Pauline Varlet

Biologist at the Department of Immunology and Histocompatibility.


Specific expertise:
Hematopoietic stem cell transplantation, HLA typing, T cell subset phenotyping, T cell activation, Alloreactivity

David Beauvais

Physician in the department of Hematology


Specific expertise:
in charge of CAR-T cells programme in the Hematopoietic Stem Cell Transplantation Unit

Address

Lille University Hospital
Avenue Oscar Lambret, 2
59037 Lille, France

www.chru-lille.fr

Patient Contact

Alexandra Preau
  Email

Bundesinstitut für Impfstoffe und Biomedizinische Arzneimittel

General information

The Paul-Ehrlich-Institut is the Federal Institute for Vaccines and Biomedicines in Germany, employs some 800 staff, and reports to the German Federal Ministry of Health. It is the German regulatory authority in the field of vaccines and biomedicinal products assessing and monitoring the benefit-risk balance before, during and after the marketing authorisation of these medicinal products. The combination of regulatory and research tasks at the PEI is unique among the European medicines agencies. Due to this sui generis position, the institute is especially qualified to provide science-based expert advice on questions concerning the quality, efficacy, and safety of vaccines and biomedicines. Regulatory science constitutes the foundation of the institute’s regulatory decision-making. Researchers at the PEI develop new methods and major reference materials for the quality and safety testing of vaccines and biomedicines. Furthermore, they investigate the causes of unexpected adverse effects, thus playing a major part in their future prevention. This is complemented by prospective basic research projects focussing on the understanding and development of innovative prophylactic and therapeutic strategies with an emphasis on novel vaccination routes and adjuvants, the efficacy of specific immunotherapy, the potential of targeted gene and (stem) cell therapy, and the treatment of cancer by oncolytic viruses and immunotherapeutics.

PEI’s division of Medical Biotechnology focuses on four research areas:

(i) development of viral and non-viral vector systems for gene therapy,
(ii) human somatic cell therapy and tissue engineering,
(iii) xenotransplantation and
(iv) parasite (virus, transposable elements) – host cell interactions.

The research group Transposition and Genome Engineering within this division is concentrating on the development of transposon-based vector systems for regenerative medicine and gene therapy.

Role in CARAMBA

As direct research input to the CARAMBA project, the PEI will be involved in developing novel technologies for non-viral gene delivery using nano-carriers as well as next-generation Sleeping Beauty transposases, site-directed transgene integration and suicide gene switch systems.

Project staff

The Bundesinstitut für Impfstoffe und Biomedizinische Arzneimittel team

Zoltán Ivics

Head of Division at the Paul Ehrlich Institute, Member of the Board of the European Society of Gene and Cell Therapy (ESGCT), the German Society of Gene Therapy (DGGT) and faculty member of the Center for Cell and Gene Therapy of LOEWE.


Specific expertise:

Development and application of the Sleeping Beauty transposon system for genetic engineering.

Csaba Miskey

Postdoctoral scientist


Specific expertise:

Several years of experience in molecular biology, high-throughput analysis and bioinformatics.

Tanja Diem

Technician


Specific expertise:

Several years of experience in molecular biology, including preparation of PCR-based libraries of transposon integration sites for next generation sequencing.

Address

Paul-Ehrlich-Institut
Paul Ehrlich Strasse 51-59
63225 Langen, Germany

www.pei.de

DRK- Blutspendedienst Baden-Wuerttemberg-Hessen GmbH

General information

The DRK-Blutspendedienst (DRK-BSD) is part of the German Red Cross Blood Service Baden-Württemberg-Hessen gGmbH which consists of 18 sites and institutes across Germany. It is one of the world’s largest blood services. The DRK-BSD runs state of the art GMP facilities and has long-standing expertise in GMP manufacturing, quality control, quality management and pharmaceutical regulation. As such the DRK-BSD has decade-long experience in producing blood products, cell based medicines and advanced therapeutic medicinal products (ATMPs). Several of the DRK-BSD institutes, specifically including the Frankfurt institute, are at the same time academic institutes (Goethe University, Frankfurt), combining clinical service in transfusion medicine, teaching and research/development. Thus the Professor of Translational Development of Cellular Therapeutics of Goethe University is the Head of the GMP Core Facility which is physically and organisationally located within the DRK-BSD Frankfurt institute. The DRK-BSD has developed and manufactured numerous cell-based therapies and has successfully brought three ATMPs to national marketing authorization in Germany.

Role in CARAMBA

DRK-BSD’s role within the CARAMBA consortium consists in the development of manufacturing and quality control processes for the car modified cell product, regulatory affairs, as well as the technology transfer to collaborating centers.

Project staff

Halvard Bönig

LOEWE- Professur für Translationale Entwicklung von Zelltherapeutika; Institut für Transfusionsmedizin und Immunhämatologie

Specific expertise:
LOEWE- Professur für Translationale Entwicklung von Zelltherapeutika; Institut für Transfusionsmedizin und Immunhämatologie

Institute Website

Michael Reiser

Postdoctoral scientist


Specific expertise:

Several years of experience in immunology, molecular biology and cellular biology.

Address

DRK-Blutspendedienst Baden-Württemberg – Hessen gGmbH (DRK-BSD)
Sandhofstrasse 1
60528 Frankfurt, Germany

www.blutspende.de
  Email

Myeloma Patients Europe

General information

Myeloma Patients Europe (MPE) plays an important role in CARAMBA through the activities related with dissemination and communication to the patient community and general population, as well as serving as the nexus with the main national patient organisations across Europe through its dense network.

MPE is an umbrella organisation of myeloma patient groups and associations. It is registered as a non-profit organisation (AISBL) under Belgian law and its headquarter is in Brussels. It currently has 41 members based in 29 countries across Europe and further afield. It also had a number of associate members from the AL amyloidosis community.

The central strategic objectives of MPE are:

  • Collaborating on national and international projects that benefit the myeloma community
  • Exchanging information and best practice
  • Developing existing patient/carer groups and associations and facilitating the creation of new ones
  • Shaping appropriate health-related policies and initiatives at European and national levels
  • Ensuring patients across Europe have timely access to the medicines that will benefit them
  • Stimulating and promoting patient-centred research and clinical trials
  • Developing a strong evidence base on the needs and wants of myeloma patients
  • Providing information, education and outreach programmes for members

MPE achieves its objectives through representing members at a European level and through providing myeloma specific knowledge and capacity building programmes. The primary purpose of these programmes is to develop a strong community of European myeloma advocates.

Role in CARAMBA

Having acquired extensive experience working with a range of stakeholders on issues such as patient involvement in drug development, optimum trial design and myeloma regulatory/reimbursement issues (including through membership to groups such as the European Medicines Agency Patient and Consumers Working Party [PCWP]), MPE can act as the main link with the myeloma patient community in Europe through its network and provide relevant patient and caregiver input to CARAMBA.

Furthermore, MPE possesses the infrastructure needed to promote education and information regarding CAR T-cell therapy and the outcomes of the CARAMBA project.

Project staff

Ananda Plate

Ananda Plate

Chief Executive Director


Specific expertise:

Several years of experience in immunology, molecular biology and cellular biology.

Kate Morgan

Policy and Public Affairs Manager


Specific expertise:
Health policy, drug regulation, reimbursement and health technology assessment, patient involvement in healthcare and patient advocacy.

Ana Vallejo

Ana Vallejo

Communications Manager


Specific expertise:

Public relations, press and media work, audio-visual communication, patient advocacy, developing communication strategies.

Address

Myeloma Patients Europe AISBL
Avenue Louise 149/24
1050 Brussels, Belgium

www.mpeurope.org
  Email

NBE Therapeutics

General information

NBE is a Swiss SME that has been founded in 2012, currently employing 23 employees, that has developed a variety of technology platforms for the development of antibodies and next-generation antibody drug conjugates for improved cancer therapy. Dr. Ulf Grawunder, CEO of NBE-Therapeutics and successful Biotech entrepreneur has more than 15 years of commercial expertise in the field of developing antibody-based anti-cancer therapeutics. Using NBE’ s antibody discovery development and engineering capabilities, NBE can on one hand provide optimal binding domains and/or input for the optimal design of specific for the SLAMF7 target, as well as providing input in the design of the optimal CAR format. Also, NBE has developed proprietary technologies for the development of site-specifically conjugated ADCs coupled to ultra-potent anthracycline toxophores. Lastly, because NBE has been commercially active for 5 years in the antibody and ADC development field, significant expertise has been accumulated in developing business and IPR strategies for biologic drug development, and in analyzing FTOs inrelevant hemato-oncological indications, including Multiple Myeloma.

Role in CARAMBA

NBE is involved in the development of a safety mechanism for controlling SLAMF7 CAR-T cell products by development/engineering of anti-SLAMF7 CAR antibody drug conjugates (ADCs). Further, NBE contributes significantly to the identification and protection of intellectual property from results of the CARAMBA project and commercial translation of the SLAMF7 CAR-T cell products.

Project staff

The NBE Therapeutics team

Ulf Grawunder

CEO NBE Therapeutics


Specific expertise:
Commercial expertise in building Biotech start-up companies in the area of antibody discovery and development.

Emile Frugier

Intellectual property manager at NBE and responsible for the development of IPR strategies and FTO analyses


Specific expertise:
Intellectual property management, commercial and entrepreneurial expertise.

Manfred Briendl

Research Associate


Supporting the ADC conjugation process.

Ina Hellmann

Group leader at NBE with the responsibility of development of ADCs in the indication of various hematological malignancies, incl. Multiple Myeloma


Specific expertise:
Expert in antibody and ADC development and immune-oncology.

Roger Beerli

CSO NBE Therapeutics


Responsible for the coordination of the Research and Discovery Programs at NBE.

Rémy Gébleux

Research Scientist II and Group leader


Responsible for ADC development and conjugation.

Address

NBE-Therapeutics Ltd.
Hochbergerstrasse 60C
4057 Basel, Switzerland

www.nbe-therapeutics.com
  Email

T-CURX GmbH

General information

T-CURX has been incorporated in 2017 as a high-tech life-science spin-off of the University of Würzburg, Germany, with the objective to develop and to bring curative CAR-T cell immunotherapies to the market for the benefit of large numbers of cancer patients (hence the name: T = T cell, CUR=cure, X=by transplantation). The company is located at the Innovations und Gründerzentrum (IGZ, engl.: Innovation and Start-up Center Würzburg, Germany). The academic founders of T-CURX have received the prestigious m4 Award of the Free State of Bavaria in 2016, acknowledging their innovation potential and competitiveness in the rapidly evolving CAR-T space.

The T-CURX founders and staff have the expertise and know how to lead the comprehensive market and competitor analyses, on which basis the business concepts for a going-to-market strategy and the commercial translation by T-CURX can be implemented.

T-CURX is a new spin-out and is on a trajectory for rapid expansion. It is anticipated that T-CURX will rapidly reach the operational capacity in order to adopt the SLAMF7 CAR-T cell product after completion of phase I/IIa safety/efficacy testing in CARAMBA and will be able to lead the subsequent development of the cell product to market authorization – either alone or in collaboration with major biotech or pharma positioned in the myeloma space.

Role in CARAMBA

T-CURX leads the identification and protection of intellectual property, market and competitor research in the field of CAR-T cells in myeloma, as well as the development of reimbursement and business models for the SLAMF7 CAR-T cell products. Further, T-CURX shall lead the development to market authorization and commercial translation of the SLAMF7 CAR-T cell product after completion of the Phase I/IIa clinical trial in CARAMBA.

Project staff

Christian SÖLLNER

Christian SÖLLNER

Managing Director


Specific expertise:
Biotech & industry leadership; Legal and regulatory affairs, Business development, Intellectual property management and protection

Dr. Benedikte Hatz

Dr. Benedikte Hatz

Head of Licensing and Business Development


Specific expertise:
More than 20 years of experience in high-tech start-up environment and life sciences industry comprising management of business development, venture capital investments, investor & industry relations, intellectual property protection and general commercial development of medicinal products. PhD in molecular biology from the TU Munich and  MBA from the Open University, UK

Address

T-CURX GmbH
Friedrich-Bergius-Ring 15
97076 Wuerzburg, Germany

www.t-curx.com
  Email

ARTTIC SAS

General information

ARTTIC is the leading European group providing consultancy and management services to international technology-related partnerships. The ARTTIC group comprises several companies with offices in France, Belgium, Germany, the UK and Israel. ARTTIC has gathered experience and knowledge in various RDI fields. Through its involvement in more than 300 RDI projects and networks from previous EU-funding research programs, ARTTIC has developed substantial methods and tools in managing collaborative RDI projects. In the framework of FP6, FP7 and H2020, ARTTIC has managed or is currently involved in the management of more than 50 successful projects.

Role in CARAMBA

ARTTIC is running the CARAMBA Project Office through which it will provide the methods, tools and operational support to promote an effective collaboration within the consortium. It will support the consortium in the daily management, administrative and contractual tasks to ensure the project is properly monitored and decisions and actions are prepared and taken according to the project’s progress. ARTTIC aims at simplifying the contractual and administrative work requested from the researchers as much as possible. Furthermore, ARTTIC supports project communication, dissemination, IPR management and exploitation activities.

Project staff

Sabine Possmann

Sabine Possmann

Project Manager


Specific expertise:

International project management with focus on health and industrial collaboration projects. Expert for proposal development, contracts negotiation, project and finance controlling, extended knowledge of all regulatory requirements and development of project concepts and sustainability strategies.

Patrizia Torremante

Patrizia Torremante

Senior Consultant

Specific expertise:
International Projects Management with more than 13 years of experience in EC-funded research projects. Specialized on the comprehensive project management from conception of the application to final reporting and closure of projects, including contractual management, project and finance controlling and reporting, as well as communication and dissemination activities in FP7 and H2020.

Address

ARTTIC
Head offices
58A rue du Dessous des Berges
75013 Paris, France

http://www.arttic.eu

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